Are digital Technologies tools safe and Effacious?Use the following articles toFor this discussion board select two of the articles/readings from this module from The Good, Bad, and P

E1260

JACC April 5, 2011

Volume 57, Issue 14

QUALITY OF CARE AND OUTCOMES ASSESSMENT

MOBILE PHONE-BASED REMOTE PATIENT MONITORING IMPROVES HEART FAILURE MANAGEMENT

AND OUTCOMES: A RANDOMIZED CONTROLLED TRIAL

ACC Poster Contributions Ernest N. Morial Convention Center, Hall F

Monday, April 04, 2011, 3:30 p.m.-4:45 p.m.

Session Title: Outcomes in Heart Failure Abstract Category: 45. Biomedical Computing/Information Technology

Session-Poster Board Number: 1136-161

Authors: Emily Seto, Kevin J. Leonard, Joseph A. Cafazzo, Caterina Masino, Jan Barnsley, Heather J. Ross, University Health Network, Toronto, Canada, University of Toronto, Toronto, Canada

Background: Remote patient monitoring of heart failure patients has been shown to improve health outcomes. However, the efficacy of a mobile

phone-based remote monitoring system is unknown. The objective of this randomized controlled trial was to determine the effects of mobile phone-

based remote monitoring on heart failure management.

Methods: The remote monitoring (RM) group (N=50) took daily weight and blood pressure readings, weekly single-lead ECGs, and answered daily

symptom questions on a mobile phone for 6 months. Readings were automatically transmitted wirelessly to the mobile phone and then to data

servers. Alerts were sent to the patients and clinicians as required. The control (SC) group (N=50) was provided with standard of care. Paired Student

t-tests and Wilcoxon signed-rank tests (for normally and not normally distributed data, respectively) were performed on baseline and post-study

blood tests and survey responses.

Results: Approximately 70% of RM patients completed at least 80% of their daily readings over the 6 months. The Brain Natriuretic Peptide (BNP)

blood tests improved significantly only for the RM group (decrease of 178 pg/mL, p=.001) once the effect of the clinic was reduced by removing the

patients who were enrolled into the clinic for less than 6 months (35 out of 100 participants). Quality of life measured with the Minnesota Living

with Heart Failure Questionnaire also improved only for the RM group (decrease of 14 points, p=.02) using all patient data. Self-care maintenance

(p=.05) and management (p=.03) measured with the Self-Care of Heart Failure Index had an improvement for only the RM group after removing new

patients in the analysis. No differences were found between the RM and SC groups in terms of hospitalization or emergency department visits.

Conclusion: Mobile phone-based remote monitoring systems are a scalable and cost-effective form of remote patient monitoring. In this study,

we showed that a mobile phone-based remote monitoring system improved heart function, quality of life, and self-care. To achieve these positive

outcomes, reductions in healthcare resource utilization might not immediately occur, but savings could be realized in the long-term.

Abstracts e137

data were adjusted for baseline demographic and clinical variables involved in CV risk. In contrast, an increased frequency of BP control to either <140/90 mmHg or <130/80 mmHg did not have any effect on incidence and adjusted risk of myocardial infarction and heart failure. A more frequent BP control reduced the incidence of the primary outcome (combined fatal and non fatal CV events) only for the <140/90 target.

Conclusion: In patients at high CV risk achieving the target BP values rec- ommended by guidelines may lead to cerebral and renal protection but not to cardiac protection, the relative prevalence of these events determining the overall effect on cardiovascular events combined. Thus, the appropriateness of these recommendations and the clinical conditions in which they should be implemented need to be further clarified.

9A.09 BENEFITS AND PSYCHOLOGICAL RISKS OF M-HEALTH REMOTE PATIENT MONITORING OF HYPERTENSION IN DIABETES: A 1-YEAR RANDOMIZED CONTROLLED TRIAL

A. Tisler1, J. Irvine2, W. McIsaac2, D. Feig2, J. Cafazzo2, A. Logan2

1Semmelweis University, Budapest-Hungary, 2University of Toronto, Toronto-Canada

Objectives and Design: Home blood pressure (BP) monitoring actively engages patients in their own care, but the psychological consequences of enhancing self- care are unknown. We undertook a 1-year RCT to test the effectiveness of a mobile BP telemonitoring (TM) system in reducing BP and assess its effect on several psychological variables.

Methods: Adult diabetic patients with uncontrolled systolic hypertension were randomly assigned to monitor their BP at home in the standard manner (n = 55, control group) or using a fully automated TM system (n = 55, TM group). After each reading, TM patients automatically received progress and coaching messages, and if necessary, alerts and reminders. Physicians were sent sum- mary reports and critical alerts. All patients had two different BP measures (24-h ambulatory BP monitoring and 7-days of home BP readings) and com- pleted a set of psychological questionnaires at entry and exit. Primary care physicians made all treatment decisions.

Results: There was a significant decrease in daytime, nighttime, and 24-h systolic BP of 9.1 ± 15.6, 6.7 ± 15.9, and 8.7 ± 14.7 mm Hg (mean ± SD), respectively (p < 0.003 for all) in the TM group and no significant changes in the control group. Mean between-group differences in daytime and 24-h systolic BP of 7.1 ± 2.3 and 6.8 ± 2.4 mm Hg (mean ± SE) respectively were also significant (p < 0.005 for both) and in 7-day home readings, systolic 9.0 ± 2.4 (p = 0.0002). Mean between-group differences in diastolic BP also were highly significant (data not shown). In the Anxiety Sensitivity Index, there was a significant decrease in the control group (p = 0.034) and no change in the TM group, although there was no time by group interaction effect. In the Hospital Anxiety and Depression Scale, depression worsened significantly in the TM group (p = 0.016) and remained unchanged in the control group, and there was a borderline time by group interaction effect (p = 0.061). Both groups demonstrated a significant decrease in comfort with self-measurement of BP (p < 0.003) with no between-group difference. There was no significant between-group differences in the number of antihypertensive drug classes pre- scribed or number of doctor visits in the study year.

Conclusions: The highly beneficial effects of a mobile phone-based TM sys- tem on reducing BP in diabetic patients with uncontrolled systolic hyperten- sion were obtained at a possible cost of psychological well-being and comfort.

any difference between the three groups. PWV did not change significantly. AIx, adjusted for changes in heart rate, decreased by 3.6 ± 13.7% for the whole group, which decrease was significant only for nebivolol (–5.4 ± 11.1%). In linear regression models, changes in heart rate and in brachial systolic pressure were strong predictors of changes in AIx elicited by carvedilol and metoprolol (r2 = 0.41, and r2 = 0.46 for carvedilol and metoprolol, respectively), but did not explain changes in AIx caused by nebivolol (r2 = 0.09).

Conclusion: The “classical” beta-blocker metoprolol and the newer beta blockers carvedilol and nebivolol decrease central blood pressure equally. Their impact on pressure augmentation seems to be different, however, with nebivolol having the largest potential of decreasing heart rate-adjusted AIx. While AIx changes associated with carvedilol and metoprolol treatment are strongly driven by peripheral blood pressure and heart rate changes, those associated with nebivolol treatment seem to be the result of other mechanisms.

9A.08 BLOOD PRESSURE TARGETS RECOMMENDED BY GUIDELINES AND INCIDENCE OF CARDIOVASCULAR AND RENAL EVENTS IN THE ONTARGET TRIAL

G. Mancia1, H. Schumacher2, J. Redon3, P. Verdecchia4, R. Schmieder5, G. Jennings6, K. Yusoff7, L. Ryden8, G.L. Liu9, R. Fagard10, K. Teo11, P. Sleight12, S. Yusuf11. 1University of Milano Bicocca – San Gerardo Hospital, Milano- Italy, 2Boehringer-Ingelheim, Ingelheim-Germany, 3Carlos III, Hospital Clinico Universitario, Valencia-Spain, 4Struttura Complessa di Medicina, Ospedale di Assisi, Assisi-Italy, 5Nephrologie und Hypertensiologie, Universitätsklinikum, Erlangen-Germany, 6Baker Medical Research Institute,, Melbourne-Australia, 7Universiti Teknologi Mara, Selangor- Malaysia, 8Karolinska Intitutet, Karolinska Universitetssjukhuset Solna, Stockholm-Sweden, 9Chinese Academy of Medical Sciences, Dept. of Hypertension, Beijing-China, 10Division on Hypertension and Cardiovascular Rehabilitation, Department of Cardiovascular Diseases, Leuven-Belgium, 11Population Health Research Institute, McMaster University, Hamilton-Canada, 12CV Medicine, John Radcliffe Hospital, Oxford-United Kingdom

Background: Hypertension treatment guidelines recommend to lower blood pressure (BP) to <140/90 mmHg in all hypertensive patients but to be more aggressive, i.e. to reach <130/80 mmHg in patients with a high cardiovascular risk (CV) profile. We investigated the cardiovascular and renal benefits asso- ciated with these BP targets in the high cardiovascular risk population of the ONTARGET trial.

Methods and Results: We analyzed ‘post hoc’ 14.490 patients with a base- line BP > 140/90 mmHg (systolic/diastolic) who were divided into 4 groups according to the proportion of in-treatment visits in which BP was reduced to <140/90 mmHg: <25%, 25% to 49%, 50% to 74%, >75%. The same analysis was carried out in patients with a baseline BP > 130/80 mmHg (n = 19631) the target BP value being <130/80 mmHg. A progressive increase in the pro- portion of visits in which BP was controlled either to <140/90 mmHg and to <130/80 mmHg was associated with a progressive reduction in the incidence and the risk of stroke and renal events (endstage renal disease or doubling of serum creatinine). Compared to the group in which BP control to <140/90 mmHg was rarest in the group in which it was most frequent BP fell from 155/84 to 125/73 mmHg and stroke and renal events were reduced by 42% and 72%. For BP control to <130/80 mmHg the most frequent control was associated with a BP fall from 145/82 to 116/67 mmHg, the stroke and renal events reduction being 49% and 66%. There were also in the same groups marked beneficial effects on proteinuria. Similar findings were obtained when

tumor diameter of 3.2 cm. Fifty-six percent of patients had public insurance, and 44% had private with no variation between groups. PT recommenda- tions for rehabilitation were 25% of early patients and 42% of late patients. Medical comorbidities had a strong correlation with respective LOS (P , .0001, Mann-Whitney test). The median LOS for the early and late populations was 3 and 4 days, respectively. There was a statistically significant short LOS (,3 days) in those patients who underwent surgery early vs those in the later week (P ¼ .045, Mann-Whitney test).

CONCLUSION: Day of surgery plays a significant role in LOS for meningioma patients. Clinicians should remain aware of factors that may delay optimal patient discharge and early access to rehabilitation facilities. Studies are needed to assess the social variables that may affect LOS and the clinical and financial implications for extended hospital courses.

151 The Impact of the 2006 Massachusetts Healthcare Reform on Neurosurgical Procedures and Patient Insurance Status

Nicolas W. Villelli, MD; Rohit Das, Hong Yan, Jian Zou, Nicholas M. Barbaro, MD

INTRODUCTION: The Massachusetts Healthcare Policy of 2006 has many similarities to the Affordable Care Act (ACA). There are concerns the ACA will negatively impact case volume and reimbursement for physicians. Analyzing neurosurgical cases and patient insurance status before and after the Massachusetts policy change can provide insight into the future of neurosurgery in the American health care system.

METHODS: The Massachusetts State Inpatient Database, which provides demographic information on hospital discharges, was studied for all neurosurgical International Classification of Diseases, Ninth Revision (ICD-9) procedure codes from 2001 to 2012. Four categories of ICD-9 codes were created: Tumor, Other Cranial/Vascular, Shunts, and Spine. A comparison of case totals and uninsured cases, before and after the policy change, was performed. Data from New York were used as a control.

RESULTS: After 2008, there was a decrease in uninsured cases in all 4 categories in Massachusetts. The number of cases for Tumor and Spine were unchanged, while Other Cranial/Vascular increased. Shunt totals decreased postpolicy, but exhibited a similar trend to the control. ForNew York, Spine case total and uninsured case volume increased, while Other Cranial/Vascular case totals decreased.

CONCLUSION: After the Massachusetts Healthcare Reform, the number of uninsured individuals undergoing surgeries significantly decreased for all categories of neurosurgical procedures, but more importantly, the total number of cases did not change dramatically. To the extent that Massachusetts predicts the overall US experience, some aspects of reimbursement may be positively impacted by the ACA. Neurosurgery, which treats patients with more urgent conditions, may be affected differently than other specialties.

152 Remote, Continuous Monitoring of Patient Mobility After Discharge: A Marker for 30-Day Readmission

Blake Eaton Samuel Taylor, BA; Trae Robison, Eric Lo, BS; Kyle McCormick, BA; Eliza M. Bruce, BA; Geoffrey Appelboom, MD; E. Sander Connolly, MD

INTRODUCTION: Early unplanned readmission is a major source of avoidable morbidity, mortality, and health care expenditure. In neurosurgery, 30-day readmissions are most often due to complica- tions, the majority of which are associated with a decrease in physical activity. Wearable, commercially available motion sensors measure movements over time and transmit these data wirelessly via a smart- phone application. These novel devices have the potential to objectively monitor patient recovery and capture complications and resulting readmissions as a single end point of activity. We sought to explore patient mobility patterns after discharge and their relationship to readmission.

METHODS: Patients with a smartphone (eg, iPhone, Android) were recruited postoperatively before hospital discharge. Each was given a FitBit ZipTM (FitBit Inc., San Francisco, California) (Table 1), a motion sensor whose accuracy we have previously validated. After syncing with patients’ smartphones via Bluetooth, subjects were instructed to wear the FitBit clipped to their socks (Figure A). The number of daily steps recorded, a well-recognized surrogate of physical activity, was then monitored remotely for 30 days after discharge.

RESULTS: Of the 23 patients enrolled, 4 were readmitted. Somewhat surprisingly, we observed that the integrity of the data wasmore associated with readmission than any particular pattern of physical activity pattern (Table 2). There were no readmissions among patients with complete data (Figure B), and an 11% readmission rate (expected in neurosurgery) among those with no data. However, subjects with either intermittent data, or data that were complete for the initial 5 days but subsequently became incomplete, had 2- and 4-fold the incidence of readmission (Figure C).

CONCLUSION: Mobility sensors may be used to track patient recovery after discharge, and are scalable to a large patient population. Incomplete data may indicate poorer health status or poor compliance with wearing the device. Consistent with emerging data from others, poor compliance itself may indicate a higher risk of readmission. Our future efforts will aim to target patients at high risk of readmission and develop appropriate interventions.

153 Hacking Neurosurgical Skills Training: Resident Education on the Cheap

Jason E. Blatt, MD; Rebecca Breese, BS; Edward Yap, MD; Wes Northam, MD; Joshua E. Loewenstein, MD

INTRODUCTION: A constant conundrum for the surgical educator is the balancing act between resident training and patient safety. Surgical simulators have become attractive, allowing trainees to practice emerging skills without risking patient health. However, many surgical simulators are expensive, complex, and frequently do not offer realistic tissue or instrument manipulation. Residents typically understand the steps and anatomy of a procedure long before they develop the manual skills to perform the operation gracefully. It would therefore be valuable to develop simple surgical simulators that offer decreased complexity and faithfully reproduce the haptic experience of a given procedure.

METHODS: The North Carolina Eye Bank Surgical Skills laboratory is a surgical educational facility operated by the University of North

CNS ORAL PRESENTATIONS

CLINICAL NEUROSURGERY VOLUME 62 | NUMBER 1 | AUGUST 2015 | 215

Copyright © Congress of Neurological Surgeons. Unauthorized reproduction of this article is prohibited

ORIGINAL ARTICLE

Randomized clinical trial to assess the effectiveness of remote patient monitoring and physician care in reducing office blood pressure

Yoon-Nyun Kim1,5, Dong Gu Shin2,5, Sungha Park3 and Chang Hee Lee4

The effectiveness of remote patient monitoring and physician care for the treatment of hypertension has not been demonstrated

in a randomized clinical trial. The objective of this study was to evaluate the effectiveness of remote patient monitoring with or

without remote physician care in reducing office blood pressure in patients with hypertension. A total of 374 hypertensive

patients over 20 years of age were randomized into the following three groups: group (1) control, the patients received usual

clinical care with home BP monitoring; group (2) the patients were remotely monitored and received office follow-up; and group

(3) the patients received remote monitoring without physician office care using the remote monitoring device. For each group, in-

office follow-up care was scheduled every 8 weeks for 24 weeks. The primary end point was the difference in sitting SBP at the

24-week follow-up. No difference between the three groups was observed in the primary end point (adjusted mean sitting SBP

was as follows: group 1: −8.9±15.5mmHg, group 2: −11.3±15.9mmHg, group 3: −11.6±19.8mmHg, (NS). Significant

differences in achieving the target BP at the 24th week of follow-up were observed between groups 1 and 2. The subjects over

55-years old had a significant decrease in the adjusted mean sitting SBP in groups 2 and 3 compared with that of the control

group. Remote monitoring alone or remote monitoring coupled with remote physician care was as efficacious as the usual office

care for reducing blood pressure with comparable safety and efficacy in hypertensive patients.

Hypertension Research (2015) 38, 491–497; doi:10.1038/hr.2015.32; published online 19 March 2015

Keywords: blood pressure; home blood pressure; remote monitoring; remote physician care

INTRODUCTION

Although achieving the target blood pressure (BP) is the most important prognostic factor for the treatment of hypertension, the latest NHANES 2007–2008 survey showed that only 50.1% of all hypertensive patients met this objective.1 Numerous factors have been shown to be associated with improved BP control. Critical among these factors is the degree of patient awareness and adherence to the treatment. A previous study demonstrated that self measurement of home BP is associated with improved treatment compliance, indicat- ing that self measurement might help increase treatment adherence.2

Recent studies have shown that telemonitoring of home BP might be more effective than conventional treatment in achieving target BP.3,4

To date, no randomized clinical trial has compared the efficacy of conventional home BP monitoring to a web-based remote patient monitoring device. The clinical trial presented here had two major objectives. First, to determine whether remote monitoring home- based BP monitoring is more efficacious in reducing office BP compared with conventional treatment with home BP measurement.

Second, to determine whether there is a difference in blood pressure lowering according to web-based remote patient monitoring with or without remote physician care (LG Smart Care system, LG Electronics, Seoul, Korea).

METHODS

Study design This study was a multi-center, randomized, parallel, interventional, open-label

trial involving the following clinical centers in South Korea: Yonsei University,

Yeungnam University and Keimyung University (Clinical Trials GOV NCT

01335984). The clinical trial was performed between 20 December 2010 and 3

April 2013. The remote monitoring system used in this study was the LG Smart

Care system. The eligible participants were assigned to the three groups with equal

probability according to the randomization code. Because this study is an open-

labeled trial, blinding was not performed. The group 1 (control) patients

(n= 124) received typical clinical care using home BP monitoring validated

with the BHS protocol (UA 767PBT, A&D medical, Tokyo, Japan) with no

remote monitoring and office follow-up (FU) visits at 8-week intervals for

1Department of Internal Medicine, Division of Cardiology, Keimyung University College of Medicine, Daegu, Korea; 2Department of Internal Medicine, Cardiovascular Division, Yeungnam University college of medicine, Daegu, Korea; 3Divison of Cardiology, Severance Cardiovascular Hospital and Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, Korea and 4LG Electronics, Seoul, Korea

Correspondence: Dr S Park, Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 120-752, Korea. E-mail: [email protected]

5These authors contributed equally to this work.

Received 30 August 2014; revised 22 January 2015; accepted 26 January 2015; published online 19 March 2015

Hypertension Research (2015) 38, 491–497 & 2015 The Japanese Society of Hypertension All rights reserved 0916-9636/15 www.nature.com/hr

24 weeks.5 The subjects were instructed to measure and record their home

BP measurement in their diary and bring the data to each office visit. The

subjects were instructed on the proper intake of their medications, as well as

maintenance of their usual healthy lifestyle modifications of their dietary and

exercise habits. The group 2 (n= 124) patients received remote monitoring of

home BP through the LG Smart Care system; however, they did not receive

remote physician care. These patients receive in-office physician care at FU

appointments every 8 weeks for 24 weeks. The group 3 (n= 126) patients

received remote monitoring of home BP and remote physician care without in-

office physician care. Remote physician care was provided every 8 weeks for

24 weeks by the attending physician of the subject. For the remote monitoring,

routine contact was made with the patient every week from the 1st to 9th week

and once every 4 weeks from the 10th to the 24th week. In addition, the patient

was contacted in the following cases: (i) when the 1-week average home BP was

⩾ 160/100mmHg; (ii) when the measured BP was ⩾ 180/120mmHg; and (iii)

if the patient did not measure the BP at home for 3 consecutive days. The

patients were instructed to measure the BP at home in the dominant arm, once

in the morning and once in the evening. The patients enrolled in the remote

monitoring arm (group 2, group 3) were educated regarding the use of the

supplied netbook computer and the LG Smart Care system. All the data were

uploaded onto the server by Bluetooth and constantly monitored by healthcare

professionals (physicians, nurses, a nutritionist, an exercise trainer) involved in

the study. In addition to the BP data that was obtained, the patients were

instructed to upload the records of their daily dietary intake, as well as the types

and duration of the exercise programs, which were monitored by the

nutritionist and the exercise trainer. The adherence to anti-hypertensive

medications was assessed by records in a medication diary provided to the

patients at the time of enrollment. The adherence was calculated by the number

of days anti-hypertensive medications were taken, divided by the study

duration. Ambulatory BP was measured in the non-dominant arm using a validated

ambulatory BP monitoring (ABPM) device (A&D TM-2430, A&D

Medical, San Jose, CA, USA). The daytime average BP was defined as

the average of the BP measurements obtained from 0700 hours to 2259 hours.

The night time average BP was defined as the average of the BP measurements

obtained from 2300 hours to 0659 hours. The white-coat effect was defined as a

baseline daytime average systolic/diastolic ABPM o135/85mmHg (130/80 for

DM and/or CKD), respectively. For the patients enrolled in the web-based

monitoring-only arm (group 2), an in-person office visit to the attending

physician was required every 8 weeks. The attending physicians cared for the

patient based upon the data obtained through the remote patient monitoring,

as well as the data obtained in the office. For the patients enrolled in the remote

monitoring/remote treatment arm (group 3), the attending physician assessed

the status of the patient by remote monitoring. Anti-hypertensive medications

were adjusted and prescribed by the attending physicians according to the

patient’s data. The hypertension treatment regimen, based on the major clinical

guidelines, was left to the discretion of the attending physician.6–8 For the

remote physician monitoring arm, the necessary medications were delivered to

the patient. The study protocol and informed consent form were reviewed and approved

by the Institutional Review Board of Yonsei University Shinchon

Severance Hospital, Yeungnam University Hospital and Keimyung University

Hospital. All the procedures were performed in accordance with the institu-

tional guidelines. All the patients provided informed consent prior to being

enrolled.

Inclusion and exclusion criteria Inclusion criteria

1. Hypertensive patients over 20 years of age whose office BP was uncontrolled

with one or more anti-hypertensive medications (systolic BP (SBP)⩾ 140

mmHg; for diabetes mellitus (DM) or chronic kidney disease (CKD),

SBP⩾ 130mmHg).

Exclusion criteria

1. The patients with an average sitting SBP of 4200mmHg at the screening visit.

2. Secondary hypertension. 3. HbA1c4 11%. 4. Hypertensive patients requiring admission care. 5. CKD with a serum creatinine level of 41.5 times the upper limit of

normal. 6. Chronic liver disease with aspartate aminotransferase/alanine aminotrans-

ferase over three times the upper limit of normal. 7. History of acute myocardial infarction, acute coronary syndrome, con-

gestive heart failure and/or valvular heart disease within the last 6 months. 8. Chronic debilitating illness. 9. Autoimmune disease. 10. Patients taking medications that might influence BP (sedatives, hypnotics,

lithium, selective serotonin reuptake inhibitors, tricyclic antidepressants, nonsteroidal anti-inflammatory drugs, oral contraceptives, alpha agonists, steroids).

11. Patients with known allergies to angiotensin-converting-enzyme inhibitors or angiotensin receptor blockers.

12. Patients with a history of alcoholism.

Statistical analysis The study was initially designed to enroll 564 patients (under the assumption of a 25% dropout rate), which was later revised to enroll 495 patients equally to each of the three intervention groups, under the assumption of a 20% dropout rate because the dropout rate was lower than expected (Figure 1). With a sample size of 165 patients per group, the trial had 80% power to detect (α= 0.05; two-sided test) a between-treatment difference between the group 1 and groups 2 and 3 of 3.8mmHg in the SBP change from baseline with a s.d. for the SBP of 11.43mmHg, with a 20% dropout rate. The between-treatment difference of 3.8mmHg and an s.d. of 11.43mmHg were estimated from similar hypertension trials.9–11

The primary end point was the difference in the sitting SBP at the 24th week of FU by the intention-to-treat (ITT) analysis compared with the baseline measurement. The secondary end points were as follows: (i) the difference in the sitting diastolic BP (DBP) at the 24th week of FU by the ITT analysis compared with the initial measurement; (i

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